A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis

• Status: Completed
• Trial end date: 2014-11-10
• Target enrollment: 0
• Participant gender: All

Summary

To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: ASP7991; Cinacalcet; Cinacalcet Hydrochloride

Criteria

Inclusion Criteria:

• Patients who are on stable chronic maintenance dialysis who are receiving hemodialysis therapy 3 times/week since before 12-week (84 days) administration and are also scheduled to undergo the regimen of 3 times/week hemodialysis during the study period

• Patients with secondary hyperparathyroidism

• Patients whose serum iPTH concentration is >240 pg/mL and corrected serum Ca is ≥ 9.0 mg/dL

• Patients who have had no changes in the following items ≥4-week (28 days).

• Dosage and regimen, including new administration, of active vitamin D, calcitonin preparation, phosphate binder, and medication with phosphate absorption (including foods)

• Ca concentration of the dialysate, membrane area of the dialyzer, and dialysis time of each week

Exclusion Criteria:

• Patients who underwent parathyroid intervention, such as parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT), within 24 weeks (168 days) prior to the administration

• Patients who have primary hyperparathyroidism

• Patients who received bisphosphonate, estrogen preparation, parathyroid hormone within 4 weeks (28 days)

• Patients with uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and diastolic blood pressure ≥ 120 mmHg are observed at >2/3 of all confirmable measurements

• Patients who are complicated by severe heart disorder [congestive cardiac failure (NYHA classification III or higher), or wide range of old myocardial infarction], or having a history of hospitalization for cerebro-vascular disease or heart disorder within 12 weeks (84 days) before administration of the study drug

• Patients with hepatic function abnormal (ALT or AST is >2× ULN, or total bilirubin (T-bil) is > 1.5 × ULN.)

• Patients with a history of malignant tumor or the patient's condition is complicated by malignant tumor. (However, enrollment is acceptable if the tumor has not relapsed for 5 years or longer.)

• Patients with a history of serious drug allergy including anaphylactic shock

• Patients with a history of drug allergy to Cinacalcet hydrochloride

• Female patients who are potentially child-bearing or lactating, or patients who do not comply with the instructed contraceptive measures

• Patients who were or are currently involved in trials for other investigational drugs or medical devices, or clinical trial for post-marketing study drugs within 12 weeks (84 days) before the study

• Patients who have received ASP7991 in the past

• Patients who were judged ineligible to participate in the study by the

investigator / subinvestigator